Operators Manual
11 Pages
Preview
Page 1
Operator's Manual FW400 Series Blood/Fluid Warmer Table of Contents Section
Description
1.0 2.0 3.0 4.0 5.0 6.0
Page
Indications for Use/Safety Precautions ... 1 Product Description ... 2 Instructions for Use ... 5 Safety Systems ... 7 Troubleshooting and Maintenance ... 8 Technical Specifications ... 9
Before you begin. . . Important Before using the Medi-Temp II FW400/FW401/REF FW403 (FW400 Series) Blood/Fluid Warmer, please read and understand this Operator's Manual and the SAFETY PRECAUTIONS prior to each application. If you have any questions, please contact your local dealer for assistance.
Warranty The Medi-Temp II FW400 Series Blood/Fluid Warmer is warranted free of defects in material and workmanship for a period of one (1) year. The Disposable Warming Sets are warranted free of defects in material and workmanship for a single application. A copy of the warranty is available upon request. Gaymar disclaims all implied warranties including, but not limited to, the implied warranties of merchantability and of fitness for a particular purpose.
Medi-Temp II is a trademark of Gaymar Industries, Inc. © 2000. Gaymar Industries, Inc. All rights reserved. www.gaymar.com
Operator's Manual FW400 Series Blood/Fluid Warmer 1.0
Indications for Use
This device is intended to aid in the prevention of inadvertent hypothermia during administration of blood, blood products, and other fluids.
1.1
Safety Precautions DANGER
CAUTION
Risk of electric shock. Refer servicing to qualified medical service personnel.
• U.S. Federal law restricts this device to sale by or on the order of a physician.
WARNING
• Do not immerse in cleaning and/or sterilization solution. Do not submerge or soak unit; it is fluid-resistant, not fluid-proof.
• All air must be removed from the fluid lines prior to connection to the patient. • Monitor the fluid lines to insure they are air free. Never administer fluids if there are air bubbles in the line between the bubble trap and the patient connector.
• For grounding reliability of the Blood/Fluid Warmer, plug only into a properly grounded outlet. • Do not attempt to transport the Blood/Fluid Warmer while mounted to an IV pole. It could tip over. Remove the Blood/Fluid Warmer for transport.
• Monitor the fluid level in the bubble trap frequently. Bubbles released during heating are captured in the trap. To refill the trap, insert a sterile syringe into the valve and draw air out until the trap is twothirds (2/3) full. Do not allow the bubble trap to go below one-quarter (1/4) full. See figure 5, page 6. • The bubble trap must be mounted and kept in a vertical position at all times. Failure to follow the above warnings could result in the introduction of air to the patient. Introduction of air to the patient could result in death or serious injury.
WARNING • Repairs should be performed only by qualified medical service personnel in accordance with this product's service manual. Otherwise, damage to the Blood/Fluid Warmer and improper therapy may result.
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Operator's Manual FW400 Series Blood/Fluid Warmer 2.0
Product Description
2.1
The Medi-Temp II FW400 Series Blood/Fluid Warmer is a simple, dry heat device designed for safe and rapid in-line warming of blood, blood products, and other fluids through the utilization of disposable Blood/Fluid Warming Sets. The Warmer does not provide fluid flow rate control. Blood, blood products, and other fluids at temperatures 10ºC and below will be warmed to temperatures between 36°C and 43°C at flow rates of 10 to 300 ml/min. Room temperature fluids (20°C) can be warmed at flow rates up to 500 ml/min. The disposable Blood/Fluid Warming Sets are available in Standard, Standard with Extensions, Pediatric, and High Flow models.
Warmer (see figure 1)
The Medi-Temp II FW400 Series Blood/Fluid Warmer is a sealed, fluid-resistant device. A lighted on/off circuit breaker is located on the side panel. An LED temperature display is located on the front panel. Fluid temperature is indicated in degrees Celsius on the display. Also located on the front of the unit is a slot for insertion of the Blood/Fluid Warming Set's flexible cassette. On the side of the unit is a holder for the bubble trap. The Blood/Fluid Warmer can be placed in an X-Ray cassette slot within an operating room table or on horizontal surfaces. An integral pole clamp also allows the unit to be pole mounted.
F
H
G
E
A
B C D
A
LED Temperature Display
E
Pole Clamp
B
Blue Guide Rail Location Indicator
F
Lighted On/Off Circuit Breaker
C
Disposable Flexible Warming Cassette Slot
G
Test Switch Access Screw Refer to Gaymar Medi-Temp II FW400 Series Blood/Fluid Warmer Service Manual
D
Bubble Trap Holder
H
Detachable Power Cord
Figure 1-Medi-Temp II FW400 Series Blood/Fluid Warmer
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Operator's Manual FW400 Series Blood/Fluid Warmer 2.2
Disposable Warming Sets (see figure 2)
The Medi-Temp II FW400 Series Blood/Fluid Warmer is designed to be used with Gaymar D25000 Series Blood/Fluid Warming Sets only. The following Blood/Fluid Warming Sets are available for use at this time. Check with your local dealer for more details. Each Warming Set consists of a flexible cassette (for insertion into the warmer) and a bubble trap with a manual air eliminator. They are designed for use below 300 mm Hg pressure with hospital standard intravenous (IV) administration sets and venipuncture sets utilizing luer type connectors. Each Warming Set also has input and output pinch clamps. See figure 2. The Standard Warming Set is designed for use at 300 ml/min or lower flow rates. The Standard Warming Set with Extensions provides the user with added patient lead length. The priming volume of the Standard Warming Set is 39 ml. The priming volume of the Standard Warming Set with Extensions is 48 ml.
G
A B
D
The Pediatric Warming Set has a lower priming volume of 30 ml. Its patient connection lead utilizes thicker walled tubing to provide added insulation at the lower pediatric warming flow rates. The High Flow Warming Set uses leads having a larger inner diameter. This reduces restriction during circumstances requiring rapid infusion. The priming volume of the High Flow Warming Set is 79 ml. Description
C F D
Catalog N o.
E Standard
D25340CE
Standard with Extensions
D25310CE
Standard with Extensions (60")
D25315CE
Pediatric
D25320CE
A
Flexible Cassette
E
Male Luer (to Patient)
Hi g h F l o w
D25330CE
B
Manual Air Eliminator (Relief Valve)
F
Female Luer (to Blood/Fluid Source)
C
Bubble Trap
D
Clamp
G
Blue Guide Rail
Figure 2-Medi-Temp II FW400 Series Blood/Fluid Warmer- Standard Warming Set
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Operator's Manual FW400 Series Blood/Fluid Warmer
Ê
Ë
Ì
Í 2 3
Î
Ï
Ð
Ñ
Figure 3-Instructions for Use-Setup 4
O
I
Operator's Manual FW400 Series Blood/Fluid Warmer 3.0
Instructions for Use-Setup
Select a site for placement of the Warmer. If the Warmer is attached to a pole, ensure the pole clamp is securely tightened.
CAUTION Do not attempt to transport the Warmer while mounted to an IV pole. It could tip over. Remove the Warmer for transport. Plug the power cord into a properly grounded electrical outlet. NOTE: Do not turn unit on without first inserting a Warming Set. Doing so may activate the Over Temperature Safety Thermostats. Also, do not prime the Warming Set prior to inserting it into the Warmer. Follow the instructions below (see corresponding illustrations numbered 1 through 8 on page 4). NOTE: Warming Sets are designed for use below 300 mm Hg.
Ê Remove the Warming Set from its sterile packaging.
Stretch the flexible cassette slightly and insert the front end into the front of the Warmer, aligning the rails to each edge of the slotted opening. Move hands to the rail protrusions and continue to insert the cassette until the clear guide rail is flush with the front of the unit. (The blue guide rail will protrude slightly for easy removal.)
Ë Close Warming Set input clamp. Remove the protector from the female luer of the Warming Set and connect it to the male luer on the IV administration set.
Remove the protector from the male luer of the Warming Set. To minimize temperature drop and priming volume, remove unnecessary lead extensions at this time.
Ì Invert the bubble trap. Warming Set input clamp. Allow fluid to prime Í Open the Set. When the bubble trap fills to approximately two-thirds (2/3) full, close output clamp.
Î Re-invert the bubble trap and mount it in the bubble trap holder so it is in a vertical position. WARNING
WARNING
Do not use the contents of the package if any part of the contents is damaged, distorted or contaminated. Contents are sterile and nonpyrogenic in unopened, undamaged package. NOTE: The flexible cassette is designed so it can be inserted into the Warmer in only one orientation (see figure 1, page 2). The blue guide rail on the cassette lines up with the blue guide rail indicator on the front of the Warmer. Grasp each rail (see figure 4 below) with the blue guide rail in the left hand.
The bubble trap must be mounted and kept in the vertical position at all times. Failure to do so could result in the introduction of air to the patient. The introduction of air to the patient could result in death or serious injury. the on/off circuit breaker on. The Warmer will Ï Turn perform a two-second self-check before turning on the display.
Ð If required, connect an extension for patient connection.
Ñ Purge air from remaining length of tubing by opening output clamp and allowing fluid to flow. WARNING
Air must be removed from the fluid lines prior to connection to the patient. Failure to do so could result in the introduction of air to the patient. The introduction of air to the patient could result in death or serious injury. Figure 4-Grasp and stretch flexible cassette
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Operator's Manual FW400 Series Blood/Fluid Warmer 3.1
During Use
3.2 WARNING
• Monitor the fluid lines to insure they are air free. Never administer fluids if there are air bubbles in the line between the bubble trap and the patient connector. • Monitor the fluid level in the bubble trap frequently. Bubbles released during heating are captured in the trap. Do not allow the bubble trap to go below one-quarter (1/4) full. Air can be removed from the bubble trap by inserting a sterile syringe into the Manual Air Eliminator (see figure 2, page 3) and withdrawing air until the trap is two-thirds (2/3) full. See figure 5 below. Failure to follow the above warnings could result in the introduction of air to the patient. Introduction of air to the patient could result in death or serious injury.
Figure 5-Monitoring Fluid Level
During normal operation the Warmer will indicate approximately 43.0°C on its display. If the audible alarm sounds during operation, the Warmer may not be heating. Refer to section 4.0.
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Warming Set Removal
The flexible cassette of the Warming Set cannot be removed from the Warmer when there is fluid within it. 1.
Drain the Warming Set of fluid.
2.
Remove bubble trap from holder.
3.
Pull blue guide rail to remove flexible cassette from Warmer.
4.
Dispose of Warming Set per hospital protocol.
Operator's Manual FW400 Series Blood/Fluid Warmer
4.0 4.1
4.3
Safety Systems
°c
Control Alarm-hI ®
Electronic System Self Check
Each time the Warmer is turned on, it performs a self-check (about 2 seconds) before lighting the display. If a problem is detected, an error code will be displayed and the Warmer must be removed from use.
If a fluid temperature over 45ºC is sensed by the Warmer, it turns the heaters off and activates an audible alarm. The display will alternately indicate the word “hI” and the temperature. The audible alarm may be silenced during this condition by turning the unit off then on again. If the fluid temperature drops below 45ºC, the unit will resume normal operation. Refer to section 5.1, page 8.
4.2
Temperature Control
The Medi-Temp II FW400 Series Blood/Fluid Warmer noninvasively senses fluid temperature on the surface of the Warming Cassette. At steady state, the Warmer indicates approximately 43.0°C on its display. Output fluid temperature will be 36°C–43°C for 10°C input fluid temperature. Fluid temperature is affected by fluid flow rate as shown in figure 6 below. Room temperature fluid may be warmed at flow rates up to 500 ml/min.
Over Temperature Safety Thermostats
°c ®
In the event of Warmer failure, there are two mechanical thermostats that will interrupt power to the heaters. The first thermostat will turn off the heaters, activate the audible alarm and turn the display blank. The second thermostat will interrupt power to the Warmer if the first one fails.
Typical Fluid Temperature (FW400 Series)
50
4.4
Cold fluid through the Warming Set can be used to reset the thermostats. The unit must be turned off, then back on to reset the alarm circuits.
48 46
Refer to section 5.1, page 8.
Temperature (°C)
44 42 40 38
4.5
36
°c
Control Alarm-LO ®
34 32 30 0
50
100
150 Flow (ml/min)
200
250
300
If the sensed fluid temperature drops below 34ºC, the Warmer will activate an audible alarm, and the display will alternately indicate the word “LO” and the temperature. Refer to section 5.1, page 8.
Figure 6 - Typical fluid temperature vs. flow values
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Operator's Manual FW400 Series Blood/Fluid Warmer 5.0
Troubleshooting and Maintenance
5.1
Troubleshooting and Servicing
Use the following checklist to identify and solve Warmer problems. If after following these guidelines, the problem persists, have unit serviced by a qualified medical service person in accordance with the Medi-Temp II FW400 Series Blood/Fluid Warmer Service Manual (contact your local dealer or Gaymar to obtain the Service Manual).
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Situation
Solution
On/off circuit breaker is not lighted.
• Check if on/off circuit breaker is on. • Check if power cord is securely attached and plugged in. • Ser vice required. Send unit for ser vicing.
Display indicates a flashing “hI”, and audible alarm is activated.
OVER TEMPERATURE CONDITION • An alarm may occur if the Warmer has been turned on prior to inser ting a Warming Cassette. 1. Turn unit off. 2. Inser t Warming Set and prime the Set. 3. Turn unit back on. • An alarm may occur if flow rate is stopped abr uptly. 1. Silence the alarm by turning the on/off circuit breaker off then on again. 2. Restar t flow of fluid to reduce sensor temperature. Proceed with use when the indicated sensor temperature is under 45°C. • If an alarm condition persists, remove from use. Send unit for ser vicing.
Display is off, on/off circuit breaker is lighted, and audible alarm is either on or off.
OVER TEMPERATURE CONDITION • Backup thermostats were activated. 1. Reduce flow rate. 2. Turn power off. 3. Run cold fluid through the Warming Set to reset the thermostat (with power off). 4. Turn power on. • If condition reoccurs, remove Warmer from use and send for ser vicing. If condition doesn't reoccur, it may have occurred due to excessively high flow rate with ver y cold fluid.
Display indicates a flashing “LO”, and audible alarm is activated.
LOWER TEMPERATURE CONDITION • An alarm may occur if a ver y high flow of cold fluid is present. The alarm should last no more than 20 seconds. • If alarm is continuous, heater circuit may be inoperative. Remove from use. Send unit for ser vicing.
Display indicates “ER2”.
Temperature sensor has failed. Remove from use. Send unit for ser vicing.
Operator's Manual FW400 Series Blood/Fluid Warmer 5.2
Cleaning
bottom to facilitate cleaning.) Use the thin brush supplied with the Warmer to clean the inside of slot. Rinse slot with warm water.
CAUTION
Wipe Warmer dry with a clean, dry cloth. Do not immerse Warmer in cleaning and/or sterilization solution. Do not submerge or soak unit; it is fluid-resistant, not fluid-proof.
Apply a disinfectant such as 10% chlorinated bleach solution (chlorinated bleach with 5.25% sodium hypochlorite) to the external surfaces of the Warmer and allow to dry.
Perform the following care and cleaning between patient use or per hospital protocol: Unplug unit prior to cleaning. To clean the external surfaces of the Warmer, use a nonabrasive cleaning solution (such as warm soapy water) and a clean cloth.
5.3
Function Check
A function check should be performed every three (3) months or as per hospital protocol by qualified medical service personnel in accordance with the Medi-Temp II FW400 Series Blood/Fluid Warmer Service Manual (contact your local dealer or Gaymar to obtain the Service Manual).
To clean the inside of the Warmer, flush the cassette slot with cleaning solution over a sink. (The slot is open at the
6.0 Technical Specifications FW400
FW401
FW403
Voltage
~120 V
~100 V
~220 V – 240 V
Current
9A
11 A
4.5 A
Capacity
1200 W
Frequency
50/60 Hz
Ambient Temperature
50 Hz
15.6°C–29.4°C (60°F–85°F)
Power Cord
Detachable, 15 feet long. Use only UL listed type SJT, 16 AWG 3-conductor cord with molded on grounding type hospital grade attachment plug.
Detachable, 4.6 meters long. Use only an international (harmonized) 3-wire cord using cordage approved to HD-21 conductor size 1.00 mm² (H05VVF3G1.00).
Classification
Class 1 grounded, splash-proof equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
IPX4 Weight
4.5 kg (10 pounds)
Size
35 mm x 235 mm x 275 mm (1 3/8" x 9 1/4" x 10 3/4")
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